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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02724163


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT02724163
Ethics application status
Date submitted
8/01/2016
Date registered
31/03/2016
Date last updated
9/11/2020

Titles & IDs
Public title
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
Scientific title
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy
Secondary ID [1] 0 0
2014-005066-30
Secondary ID [2] 0 0
RG_14-088
Universal Trial Number (UTN)
Trial acronym
Myechild01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gemtuzumab ozogamicin
Treatment: Drugs - Liposomal daunorubicin
Treatment: Drugs - Mitoxantrone
Treatment: Drugs - Fludarabine
Treatment: Drugs - Cytarabine
Treatment: Drugs - Busulfan
Treatment: Drugs - Cyclophosphamide

Active Comparator: Mitoxantrone - Course 1
Mitoxantrone: 12 mg/m2 daily by IV infusion over 1 hour on days 1, 2, 3 and 4 (total 4 doses).
Cytarabine:100 mg/m2 12 hourly by IV bolus on days 1-10 inclusive (total 20 doses).
Course 2
Mitoxantrone: 12 mg/m2 daily by IV infusion over 1 hour on days 1, 2 and 3 (total 3 doses).
Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-8 inclusive (total 16 doses).

Experimental: Liposomal daunorubicin - Course 1
Liposomal daunorubicin: 80 mg/m2 daily by 1 hour IV infusion on days 1, 3 and 5 (total 3 doses).
Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-10 inclusive (total 20 doses).
Course 2
Liposomal daunorubicin: 60 mg/m2 daily by 1 hour IV infusion on days 1, 3 and 5 (total 3 doses).
Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-8 inclusive (total 16 doses).

Experimental: Gemtuzumab Ozogamicin Dose Finding Study - Cohort 1: 1x3mg/m2 IV infusion over 2hours on day 4.
Cohort 2: 2x3mg/m2 IV infusion over 2hours on day 4 and day 7.
Cohort 3: 3x3mg/m2 IV infusion over 2hours on days 4, 7 and 10.

Active Comparator: High dose cytarabine - Two courses of Cytarabine: 3 g/m2 12 hourly by IV infusion over 4 hours on days 1, 3 and 5 (total 6 doses).

Experimental: Fludarabine & cytarabine - Two courses of:
Fludarabine: 30 mg/m2 daily by IV infusion over 30 minutes on days 1-5 inclusive (total 5 doses).
Cytarabine: 2 g/m2 daily by IV infusion over 4 hours on days 1-5 inclusive (total 5 doses).The cytarabine infusion should be started 4 hours after the start of the fludarabine infusion

Active Comparator: Myeloablative conditioning - Busulfan Area Under the Curve (AUC) 70-100mg/L x hr by IV infusion over 3 hours, given 12 hourly on days -10 to -7 (8 doses).
Cyclophosphamide 50mg/kg/day by IV infusion over 1 hour, on days -5 to -2 (4 doses).

Experimental: Reduced intensity conditioning - Busulfan AUC60-65mg/L X hr by IV infusion over 3 hours, given 12 hourly on days -5 to -2 (8 doses).
Fludarabine 30mg/m2/day by IV infusion over 30 minutes on days -8 to -3 (6 doses).


Treatment: Drugs: Gemtuzumab ozogamicin
Antibody-conjugated chemotherapy agent.

Treatment: Drugs: Liposomal daunorubicin
Anthracycline

Treatment: Drugs: Mitoxantrone
DNA-reactive agent

Treatment: Drugs: Fludarabine
A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.

Treatment: Drugs: Cytarabine
Pyrimidine nucleoside analogue, an antineoplastic agent.

Treatment: Drugs: Busulfan
Alkylsulfonate

Treatment: Drugs: Cyclophosphamide
A nitrogen mustard alkylating agent from the oxazaphosphorine group

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicities (DLTs).
Timepoint [1] 0 0
Incidence of DLTs will be evaluated up to day 45 post course 1 and course 2 of induction chemotherapy.
Primary outcome [2] 0 0
Event Free Survival (EFS). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.
Timepoint [2] 0 0
Event free survival (EFS) will be evaluated as the time from randomisation one to the first event, up to 16 years.
Primary outcome [3] 0 0
Event Free Survival (EFS). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.
Timepoint [3] 0 0
Event free survival (EFS) will be evaluated as the time from randomisation two to the first event, up to 16 years..
Primary outcome [4] 0 0
Relapse free survival (RFS). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 24 months along with 95% confidence intervals.
Timepoint [4] 0 0
Relapse free survival (RFS) will be evaluated as the time of randomisation three to the first relapse or death from any cause, up to 16 years.
Primary outcome [5] 0 0
Early treatment related adverse reactions. - Early treatment related adverse reactions defined as the incidence by day 100 post-transplant of grade 3-5 toxicity for the following systems using the National Cancer Institute (NCI) Common Terminology Criteria v4:
Cardiac (pericardial effusion/Left ventricular systolic dysfunction).
Respiratory, thoracic and mediastinal (hypoxia/pneumonitis).
Gastrointestinal (GI) (diarrhoea/typhlitis/upper and lower GI haemorrhage).
Investigations (bilirubin).
Renal and Urinary (acute kidney injury/haematuria).
Nervous system (seizure).
Timepoint [5] 0 0
Early treatment related adverse reactions will be evaluated at day 100 post-transplant.
Primary outcome [6] 0 0
Relapse free survival (RFS). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 12 months along with 95% confidence intervals.
Timepoint [6] 0 0
Relapse free survival (RFS) will be evaluated as the time of randomisation four to the first relapse or death from any cause, up to 16 years.
Secondary outcome [1] 0 0
The nature, incidence and severity of adverse events (AEs) (gemtuzumab ozogamicin dose finding study).
Timepoint [1] 0 0
Evaluated by day 45 post course 1 and course 2.
Secondary outcome [2] 0 0
Response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment (gemtuzumab ozogamicin dose finding study). - Response is assessed by morphology confirmed by MRD levels measured by flow cytometry, molecular methods or fluorescence in situ hybridisation (FISH) as defined in the protocol, in combination with platelet and neutrophil counts. These results of these assessments will be combined to determine the patient's disease response using the response criteria defined in the protocol.
Timepoint [2] 0 0
Evaluated by day 45 post course 1 and course 2.
Secondary outcome [3] 0 0
Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Clearance (CL) (gemtuzumab ozogamicin dose finding study) - Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort.
Timepoint [3] 0 0
Evaluated up to one month after the first dose of gemtuzumab ozogamicin.
Secondary outcome [4] 0 0
Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Volume of distribution (Vd) (gemtuzumab ozogamicin dose finding study) - Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort.
Timepoint [4] 0 0
Evaluated up to one month after the first dose of gemtuzumab ozogamicin.
Secondary outcome [5] 0 0
Complete remission (CR) (R1 & R2). - Evaluated using remission status at completion of course 1 and course 2.
Timepoint [5] 0 0
Evaluated and presented at the completion of course 1 and 2 of treatment up to a maximum of 45 days post each course of treatment
Secondary outcome [6] 0 0
Reasons for failure to achieve CR (R1 & R2). - Evaluated as resistant disease, induction death or not evaluable.This will be evaluated at completion of course 1 and 2 of treatment, once patient's blood counts have recovered or reason for non-recovery has been determined.
Timepoint [6] 0 0
Evaluated and presented at the completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.
Secondary outcome [7] 0 0
Cumulative Incidence of Relapse (CIR) (all randomisations). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. CIR estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4.
Timepoint [7] 0 0
Evaluated as time from randomisation to the relevant question to relapse, up to 16 years.
Secondary outcome [8] 0 0
Death in CR (DCR) (R1, R2 & R3). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. DCR estimates will be presented at 24 months along with 95% confidence intervals.
Timepoint [8] 0 0
Evaluated as time from randomisation to relevant question to date of death from any cause in patients who have achieved CR, up to 16 years.
Secondary outcome [9] 0 0
Event Free Survival (EFS) (R1, R2 & R3). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.
Timepoint [9] 0 0
Evaluated as time from randomisation to the relevant question to the first of failure to achieve CR (recorded as an event on day 1), relapse, secondary malignancy or death from any cause, up to 16 years.
Secondary outcome [10] 0 0
Overall Survival (OS) (all randomisations). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. OS estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4.
Timepoint [10] 0 0
Evaluated as time from randomisation to the relevant question to death from any cause or date last seen for patients who are alive at the end of the trial, up to 16 years.
Secondary outcome [11] 0 0
Incidence of toxicities (all randomisations).
Timepoint [11] 0 0
Evaluated 30 days after end of trial treatment.
Secondary outcome [12] 0 0
Incidence of cardiotoxicity (R1, R2 & R4 only).
Timepoint [12] 0 0
Evaluated 30 days after end of trial treatment.
Secondary outcome [13] 0 0
Incidence of bilirubin of grade 3 of higher (R2 & R4 only).
Timepoint [13] 0 0
Evaluated 30 days after end of trial treatment.
Secondary outcome [14] 0 0
Incidence of Veno-Occlusive Disease (R2 & R4 only).
Timepoint [14] 0 0
Evaluated 30 days after end of trial treatment.
Secondary outcome [15] 0 0
Minimal Residual Disease (MRD) clearance after course 1 & 2 (R1 & R2 only). - Evaluated using MRD result at completion of course 1 and 2 once patient's blood counts have recovered or reason for non-recovery has been determined.
Timepoint [15] 0 0
Evaluated and presented at completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.
Secondary outcome [16] 0 0
Time to haematological recovery (all randomisations). - Evaluated using the date of haematological recovery (platelets to >=80 x 10^9/L, and neutrophils to >=1.0 x 10^9/L). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. Time to haematological recovery estimates will be presented at 45 days post course 1 and course 2 of treatment along with 95% confidence intervals.
Timepoint [16] 0 0
Evaluated by day 45 post course 1 and course 2.
Secondary outcome [17] 0 0
Days in hospital after each course of treatment (all randomisations). - Total number of days spent in hospital for each course of treatment, collected from date of randomisation until count recovery after final course of treatment, up to a maximum of 45 days post the final course of treatment. This will be summarised per course of treatment.
Timepoint [17] 0 0
Evaluated once all patients have completed trial treatment.
Secondary outcome [18] 0 0
Incidence of mixed chimerism at day 100 post-transplant (R4 only).
Timepoint [18] 0 0
Evaluated at day 100 post-transplant.
Secondary outcome [19] 0 0
Treatment Related Mortality (TRM) (R4 only). - The primary analysis will be carried out once the last patient has a minimum of 1 year follow up which is estimated to be 7 years after the start of recruitment. TRM estimates will be presented at 12 months along with 95% confidence intervals.
Timepoint [19] 0 0
Evaluated as time in days between randomisation to R4 and death which is unrelated to the underlying disease and considered related to the transplant procedure.
Secondary outcome [20] 0 0
Gonadal function (R4 only). - The method of assessment will be by scale (Tanner scale) and physiological parameters. This will be evaluated at 1 year post-transplant and at the end of study follow-up.
Timepoint [20] 0 0
Evaluated at 1 year post-transplant and at the end of follow-up, which is estimated to be through to study completion, an average timeframe of 10 years.

Eligibility
Key inclusion criteria
Inclusion criteria for trial entry and R1 randomisation.

- Diagnosis of acute myeloid leukaemia (AML) /high risk Myelodysplastic syndrome (MDS)
(>10% blasts in the bone marrow)/isolated myeloid sarcoma (MS) (either de novo or
secondary).

- Age <18 years.

- No prior chemotherapy or biological therapy for AML other than that permitted in the
protocol.

- Normal cardiac function defined as fractional shortening =28% or ejection fraction
=55%.

- Fit for protocol chemotherapy.

- Documented negative pregnancy test for female patients of childbearing potential.

- Patient agrees to use effective contraception (patients of child bearing potential).

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in the gemtuzumab ozogamicin dose finding study:

Centres must be formally activated in order to be take part in the embedded dose escalation
study. Please contact the trial office for further information.

- Patient meets the inclusion criteria for trial entry.

- Age:

- =12 months for the major dose finding study

- = 12 weeks and <12 months for the minor dose finding study

- Karnofsky or Lansky performance score of =50.

- Normal renal function defined as calculated creatinine clearance =90ml/min/1.73m2.

- Normal hepatic function defined as total bilirubin =2.5 upper limit of normal (ULN)
for age unless it is caused by leukaemic involvement or Gilbert's syndrome or similar
disorder.

- Alanine transaminase (ALT) or aspartate transaminase (AST) =10 x ULN for age.

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in R2 (randomisation not yet open).

- Patient meets the inclusion criteria for trial entry

- Age =12 weeks.

- Karnofsky or Lansky performance score of =50.

- Normal renal function defined as calculated creatinine clearance =90ml/min/1.73m2.

- Normal hepatic function defined as total bilirubin =2.5 ULN for age and not due to
leukaemic involvement or Gilbert's syndrome or similar disorder.

- ALT or AST =10 x ULN for age.

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in R3.

- Patient meets the inclusion criteria for trial entry

- Induction treatment as per MyeChild 01 protocol or treated with 2 courses of
mitoxantrone & cytarabine off trial.

- Minimal residual disease (MRD) response (performed in MyeChild 01 centralised
laboratories, see national MyeChild 01 Laboratory Manual):

- Patients with good risk cytogenetics/molecular genetics and a MRD level <0.1% by
flow after course 2, or a decrease in transcript levels of >3 logs after course 2
for those with an informative molecular marker, but without an informative marker
of sufficient sensitivity for flow MRD monitoring or

- Patients with intermediate risk cytogenetics/molecular genetics with a MRD level
<0.1% by flow after course 1 and course 2, or a decrease in transcript levels of
>3 logs after course 1 and course 2 for those with an informative molecular
marker, but without an informative marker of sufficient sensitivity for flow MRD
monitoring.

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in R4.

- Patient meets the inclusion criteria for trial entry

- Induction treatment as per MyeChild 01 protocol or treated with 1 or 2 courses of
mitoxantrone & cytarabine ± treatment intensification with fludarabine, cytarabine &
idarubicin (FLA-Ida) off trial.

- Patient is in complete remission (CR) or CR with incomplete blood count recovery (CRi)
defined as <5% blasts confirmed by flow cytometry/ molecular/FISH in a bone marrow
aspirate taken within 6 weeks prior to randomisation to R4.

- Patient meets one of the following criteria and is a candidate for HSCT as per the
protocol:

- High risk after course 1 (all patients with poor risk cytogenetics and patients
with intermediate risk cytogenetics who fail to achieve CR/CRi).

- Intermediate risk cytogenetics with MRD >0.1% after course 1 and 2 measured by
flow. If no flow MRD marker of sufficient sensitivity is identified, a molecular
MRD marker with a sensitivity of >0.1% may be used.

- Good risk cytogenetics with flow MRD >0.1% confirmed by a decrease in molecular
MRD of <3 logs or rising transcript levels after course 3 despite treatment
intensification (FLA-Ida) and after discussion with the Clinical Co-ordinators.

- Availability of a 9-10/10 human leukocyte antigen (HLA) matched family or unrelated
donor or 5-8/8 matched cord blood unit with an adequate cell dose as defined by the
protocol section 17.1.

- Written informed consent from the patient and/or parent/legal guardian.
Minimum age
No limit
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for all randomisations

- Acute Promyelocytic Leukaemia.

- Myeloid Leukaemia of Down Syndrome.

- Blast crisis of chronic myeloid leukaemia.

- Relapsed or refractory AML.

- Bone marrow failure syndromes.

- Prior anthracycline exposure which would inhibit the delivery of study anthracyclines.

- Concurrent treatment or administration of any other experimental drug or with any
other biological therapy for AML.

- Pregnant or lactating females.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Women and Children's Hospital Adelaide - Adelaide
Recruitment hospital [2] 0 0
Queensland Children's Hospital - Brisbane
Recruitment hospital [3] 0 0
Monash Children's Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Childrens Hospital - Melbourne
Recruitment hospital [5] 0 0
John Hunter Children's Hopsital - New Lambton Heights
Recruitment hospital [6] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [7] 0 0
Sydney Children's Hospital - Sydney
Recruitment hospital [8] 0 0
The Childrens Hospital At Westmead - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- New Lambton Heights
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment postcode(s) [7] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Amiens
Country [2] 0 0
France
State/province [2] 0 0
Angers
Country [3] 0 0
France
State/province [3] 0 0
Besançon
Country [4] 0 0
France
State/province [4] 0 0
Bordeaux
Country [5] 0 0
France
State/province [5] 0 0
Brest
Country [6] 0 0
France
State/province [6] 0 0
Caen
Country [7] 0 0
France
State/province [7] 0 0
Clermont-Ferrand
Country [8] 0 0
France
State/province [8] 0 0
Dijon
Country [9] 0 0
France
State/province [9] 0 0
Grenoble
Country [10] 0 0
France
State/province [10] 0 0
Lille
Country [11] 0 0
France
State/province [11] 0 0
Limoges
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Montpellier
Country [15] 0 0
France
State/province [15] 0 0
Nancy
Country [16] 0 0
France
State/province [16] 0 0
Nantes
Country [17] 0 0
France
State/province [17] 0 0
Nice
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Poitiers
Country [20] 0 0
France
State/province [20] 0 0
Reims
Country [21] 0 0
France
State/province [21] 0 0
Rennes
Country [22] 0 0
France
State/province [22] 0 0
Rouen
Country [23] 0 0
France
State/province [23] 0 0
Saint-Étienne
Country [24] 0 0
France
State/province [24] 0 0
Strasbourg
Country [25] 0 0
France
State/province [25] 0 0
Toulouse
Country [26] 0 0
France
State/province [26] 0 0
Tours
Country [27] 0 0
Ireland
State/province [27] 0 0
Dublin
Country [28] 0 0
New Zealand
State/province [28] 0 0
Auckland
Country [29] 0 0
New Zealand
State/province [29] 0 0
Christchurch
Country [30] 0 0
United Kingdom
State/province [30] 0 0
County Antrim
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Aberdeen
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Birmingham
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Bristol
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Cambridge
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Cardiff
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Edinburgh
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Glasgow
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Leeds
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Liverpool
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Manchester
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Newcastle
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Nottingham
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Oxford
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Sheffield
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Birmingham
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Assistance Publique - Hôpitaux de Paris
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer Research UK
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Cancer Institute, France
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Pfizer
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is :

1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses)
is tolerated and can be safety delivered in combination with cytarabine plus
mitoxantrone or liposomal daunorubicin in induction

2. To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin
(anthracycline) & cytarabine as induction therapy.

3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of
doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with
induction chemotherapy.

4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine &
cytarabine (FLA) in standard risk patients.

5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant
(HSCT) conditioning regimens of different intensity: conventional myeloablative
conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning
(RIC) with fludarabine/busulfan.
Trial website
https://clinicaltrials.gov/show/NCT02724163
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brenda Gibson
Address 0 0
Royal Hospital for Children Glasgow
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christina Ryan
Address 0 0
Country 0 0
Phone 0 0
01214151049
Fax 0 0
Email 0 0
myechild01@trials.bham.ac.uk
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02724163

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruiting in New Zealand
Province(s)/district(s)
Christchurch Hospital Starship Hospital
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Secondary sponsor category [1] 31
Other Collaborative groups
Name [1] 31
ANZCHOG
Address [1] 31
27-31 Wright Street, Clayton VIC 3168
Country [1] 31
Australia
Ethics approval
Ethics application status
 
Public notes
Children's Hospital Westmead
John Hunter Children's Hospital
Monash Children's Hospital
Perth Children's Hospital
Queensland Children's Hospital
Royal Children's Hospital
Sydney Children's Hospital
Women's and Children's Hospital

Contacts
Principal investigator
Title 153 0
A/Prof
Name 153 0
Andrew Moore
Address 153 0
Children’s Health Queensland Hospital and Health Service Centre for Children’s Health Research 62 Graham St, South Brisbane QLD 4101
Country 153 0
Australia
Phone 153 0
+617 3069 7593
Fax 153 0
Email 153 0
Andy.Moore@health.qld.gov.au
Contact person for public queries
Title 154 0
Mrs
Name 154 0
Robyn Strong
Address 154 0
27-31 Wright Street, Clayton VIC 3168
Country 154 0
Australia
Phone 154 0
+613 8572 2684
Fax 154 0
+613 9902 4810
Email 154 0
Robyn.Strong@hudson.org.au
Contact person for scientific queries
Title 155 0
A/Prof
Name 155 0
Andrew Moore
Address 155 0
Children’s Health Queensland Hospital and Health Service Centre for Children’s Health Research 62 Graham St, South Brisbane QLD 4101
Country 155 0
Australia
Phone 155 0
+617 3069 7593
Fax 155 0
Email 155 0
Andy.Moore@health.qld.gov.au